NCT03458702

Brief Summary

A randomized repeated-measures crossover clinical trial was performed. Forty healthy, female college students completed a 30 min session of YogaFit and a time-matched seated rest condition on separate days. After each condition, participants viewed 30 min of emotional picture stimuli. State anxiety, heart rate and time-domain and frequency-domain measures of HRV were assessed baseline, post- condition, and post-exposure to emotional stimuli. Data were analysed using a condition x time (2 × 3) repeated-measures ANOVA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 25, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

February 16, 2018

Results QC Date

December 3, 2018

Last Update Submit

November 20, 2019

Conditions

Keywords

autonomic functionemotionheart rate variability

Outcome Measures

Primary Outcomes (5)

  • STAI-Y1 Score Assessed at Baseline, Post-Condition and Post-Exposure

    State anxiety (STAI-Y1 score) at baseline ( 10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after completion of 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)) was measured by Spielberger's 20 question State Anxiety Questionnaire (STAI-YI). Scores range from 20-80, with higher scores indicative of increased state anxiety.

    10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli

  • Heart Rate Assessed at Baseline, During Condition, Post-Condition and Post-Exposure

    HR in beats per min assessed utilizing three electrodes and ProComp Infiniti Software at baseline (10 min prior to condition), during the condition (30 min of YogaFit and Quiet Rest), post-condition (10 min after YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)).

    10 min prior to condition, 30 min during condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli

  • Root Mean Square of Successive Differences (RMSSD) Assessed at Baseline, Post-Condition and Post-Exposure

    A measure of HRV, RMSSD, was assessed using three electrodes and CardioPro Infiniti-HRV Analysis Software at baseline (10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)). HRV is associated with good health: increased RMSSD is thought to be beneficial.

    10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli

  • Low-frequency Band (LFNU) Assessed at Baseline, Post-Condition and Post-Exposure

    A measure of HRV, LFNU, assessed using three electrodes and CardioPro software at baseline (10 min prior to condition), post-condition (10 min after YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)). Low frequency (LF) is defined as 0.04-0.15 Hz (cycles per s) or a band ranging from 0.04 Hz to 0.15 Hz. High frequency (HF) is defined as a band ranging from 0.15-0.4 Hz (cycles per s). The most common frequency domain parameters include the powers in absolute and relative terms and the normalized power of the HF and LF bands or expressed as normalized units. The formula for n.u. for LF = LF in ms2/LF in ms2 + LF in ms2 HRV is associated with good health: increased LFNU is thought to be beneficial.

    10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli

  • High-frequency Band (HFNU) Assessed at Baseline, Post-Condition and Post-Exposure

    A measure of HRV, HFNU, assessed using three electrodes and CardioPro software at baseline (10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)). High frequency (HF) is defined as a band ranging from 0.15-0.4 Hz (cycles per s). Low frequency (LF) is defined as 0.04-0.15 Hz (cycles per s) or a band ranging from 0.04 Hz to 0.15 Hz. The most common frequency domain parameters include the powers in absolute and relative terms and the normalized power of the HF and LF bands or expressed as normalized units. The formula for n.u. for HF = HF in ms2/LF in ms2 + LF in ms2. HRV is associated with good health: HFNU and LFNU are negatively correlated.

    10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli

Secondary Outcomes (1)

  • RPE Assessed Post-Condition

    Post-Condition, 10 min after completion of YogaFit and Quiet Rest

Study Arms (2)

YogaFit then Quiet Rest

EXPERIMENTAL

Participants participated in a 30 min YogaFit and then a session of 30 min of Quiet Rest on a separate day.

Behavioral: YogaFitBehavioral: Quiet Rest

Quiet Rest then YogaFit

EXPERIMENTAL

Participants participated in a 30 min Quiet Rest session and then a session of 30 min of YogaFit on a separate day.

Behavioral: YogaFitBehavioral: Quiet Rest

Interventions

YogaFitBEHAVIORAL

For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.

Quiet Rest then YogaFitYogaFit then Quiet Rest
Quiet RestBEHAVIORAL

Participants completed 30 min of quiet rest

Quiet Rest then YogaFitYogaFit then Quiet Rest

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • were between 18 and 25 years of age;
  • were not suffering from any medical conditions that would influence the results or compromise safety during training-such as disorders effecting balance, or pregnancy;
  • who were not taking antidepressant or anti-anxiety medication;
  • were not clinically diagnosed with generalized anxiety disorder in the previous six months;
  • were within the normal range (± 1 SD from the M) for female college students for trait anxiety according to Spielberger's Trait Anxiety Inventory \[(STAI-Y2); range: 40.40 ± 10.15\] (Spielberger 1983);
  • were within normal (minimal to mild) levels of depression according to the Beck Depression Inventory \[(BDI); range: 0-18\] (Oliver and Simmons 1984);
  • had a normal menstrual cycle (cycles occurring less than every 26 to 35 days and lasting less than 2 or more than 7 days);
  • were not considered high-risk for dual energy x-ray absorptiometry (DEXA) based on a standardized questionnaire approved by the University Radiation Safety Committee; and
  • were familiar with yoga or had not participated in at least 3 yoga practice sessions.

You may not qualify if:

  • were less than 18 or more than 25 years of age;
  • were suffering from any medical conditions that would influence the results or compromise safety during training-such as disorders effecting balance, or pregnancy;
  • who were taking antidepressant or anti-anxiety medication;
  • were clinically diagnosed with generalized anxiety disorder in the previous six months;
  • were not within the normal range (± 1 SD from the M) for female college students for trait anxiety according to Spielberger's Trait Anxiety Inventory \[(STAI-Y2); range: 40.40 ± 10.15\];
  • were not within normal (minimal to mild) levels of depression according to the Beck Depression Inventory \[(BDI); range: 0-18\];
  • had an abnormal menstrual cycle (cycles occurring less than every 26 to 35 days and lasting less than 2 or more than 7 days);
  • were considered high-risk for dual energy x-ray absorptiometry (DEXA) based on a standardized questionnaire approved by the University Radiation Safety Committee; and
  • were not familiar with yoga or had not participated in at least 3 yoga practice sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

Related Publications (1)

  • Albracht-Schulte K, Robert-McComb J. The effects of yoga and quiet rest on subjective levels of anxiety and physiological correlates: a 2-way crossover randomized trial. BMC Complement Altern Med. 2018 Oct 17;18(1):280. doi: 10.1186/s12906-018-2343-1.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Results Point of Contact

Title
Dr. Jacalyn McComb
Organization
Texas Tech University

Study Officials

  • Jacalyn Robert-McComb, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Methods: A randomized repeated-measures crossover clinical trial was performed. Forty healthy, female college students completed a 30 min session of YogaFit and a time-matched seated rest condition on separate days. After each condition, participants viewed 30 min of emotional picture stimuli. State anxiety, heart rate and time-domain and frequency-domain measures of HRV were assessed baseline, post- condition, and post-exposure to emotional stimuli.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 8, 2018

Study Start

September 12, 2013

Primary Completion

March 15, 2014

Study Completion

May 1, 2014

Last Updated

November 25, 2019

Results First Posted

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations